On August 17, 2020 Seneca Therapeutics, Inc. ("Seneca Therapeutics") reported the appointment of James M. Hussey as Chief Executive Officer and member of the Board of Directors (Press release, Seneca Therapeutics, AUG 17, 2020, View Source [SID1234563716]). Jim has been a CEO or President for nearly 20 years and a C-Suite member at several successful biotech/pharmaceutical companies.

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"We are pleased to have a veteran CEO from the biotech/pharmaceutical industry like Jim join our team," said Dr. Paul Hallenbeck, President, Chief Scientific Officer and Founder of Seneca Therapeutics. "We will be working together to advance Seneca Valley Virus ("SVV-001") into clinical trials later in 2021".

"I am excited to join the Seneca Therapeutics team to develop SVV-001. Based on the data generated to date, I am extremely optimistic about the clinical trials planned for next year," said James M Hussey, CEO of Seneca Therapeutics. "I’m convinced that oncolytic viruses are key to the future of immunotherapy and that SVV-001 is the best-in-class oncolytic virus. SVV-001 potentially addresses over 60% of solid tumors—including some of the most refractory cancers– with safe, effective immuno-oncology products that harness the body’s own immune system to defeat cancer."

Jim joins the Seneca Therapeutics team at a pivotal moment. The company plans on entering Phase I-II clinical studies with SVV-001 in combination with a checkpoint inhibitor in neuroendocrine cancers in 2021. Seneca Therapeutics recently received FDA guidance on its clinical protocol and IND. Further, the company also recently secured important intellectual property rights including enabling technology that will allow Seneca Therapeutics to develop a companion diagnostic to identify patients likeliest to respond to SVV-001 using TEM8 and potentially other molecules. TEM8, the receptor of SVV-001, is expressed on the surface of the majority of solid tumor cells but minimally expressed on normal cells and supports SVV-001’s extensive safety profile as determined in numerous animal models and multiple clinical trials. TEM8 is expressed in many solid tumors including breast, lung, pancreatic, skin, and neuroendocrine cancers.

On August 17, 2020 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported the clearance of the pivotal ENVASARC protocol after filing the protocol with the U.S. Food and Drug Administration (FDA) as part of an Investigational New Drug (IND) application on July 15 (Press release, Tracon Pharmaceuticals, AUG 17, 2020, View Source [SID1234563715]). The application cross referenced the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology. TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the fourth quarter of 2020.

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"We are pleased to receive clearance from the FDA to initiate the pivotal ENVASARC trial of envafolimab in sarcoma and look forward to dosing the first patient in the fourth quarter of this year," said James Freddo, M.D., Chief Medical Officer of TRACON. "Immunotherapy has radically changed the treatment paradigm for a number of cancers and our hope is envafolimab will do the same for sarcoma patients who have few treatment options."

ENVASARC Study Design

Key elements for the ENVASARC pivotal trial include:

Multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States.
Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
Primary endpoint of objective response rate (ORR) with duration of response a key secondary endpoint.
Open-label format with blinded independent central review of efficacy endpoint data.
About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registrational trials. Envafolimab is currently dosing in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China. 3D Medicines and Alphamab Oncology, TRACON’s corporate partners for this program, plan to submit a BLA to NMPA in China for envafolimab in 2020 based on the ORR in MSI-H/dMMR advanced solid tumor patients. The confirmed ORR in MSI-H/dMMR colorectal cancer patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan reported at ASCO (Free ASCO Whitepaper) 2020 was 28.2%, which was nearly identical to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR colorectal cancer patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 27.9% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

On August 17, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in the two-day Fortress Biotech ("Fortress") Virtual Summit taking place on Tuesday, August 18 and Wednesday, August 19 (Press release, Mustang Bio, AUG 17, 2020, View Source [SID1234563714]). The Summit will be hosted by the B. Riley FBR, Inc., Research team and feature multiple programs from Fortress’ diversified pipeline.

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On Tuesday, August 18, Dr. Litchman will present Mustang’s gene therapy programs and participate in a panel with Harry L. Malech, M.D., Chief of the Genetic Immunotherapy Section for the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The panel will take place at 2:50 p.m. ET and registration for the event is available here.

Dr. Litchman will also present Mustang’s cancer cell therapy programs and participate in a panel with Stephen J. Forman, M.D., Professor in the Department of Hematology & Hematopoietic Cell Transplantation and Director of City of Hope’s T Cell Therapeutics Research Laboratory on Wednesday, August 19, 2020. The panel will take place at 1:20 p.m. ET and registration for the event is available here.
Following each event, the webcasts will be available on the Events page, located within the Investor Relations section of Mustang’s website, View Source, for approximately 30 days.

On August 17, 2020 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James F. Oliviero, President and Chief Executive Officer, will present a company overview and participate in a panel discussion at the Fortress Biotech Virtual Summit hosted by Mayank Mamtani, of B. Riley FBR, Inc., on Wednesday, August 19, 2020 at 1:50 p.m. ET (Press release, Checkpoint Therapeutics, AUG 17, 2020, View Source [SID1234563713]). A registration link and webcast information can be found below.

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The panel discussion will focus on cosibelimab, Checkpoint’s potentially best-in-class anti-PD-L1 antibody. Mr. Oliviero will be joined on the panel by David M. Miller, M.D., Ph.D., who will provide his insight on the use of immunotherapy in cutaneous squamous cell carcinoma ("cSCC") and the issues patients face when accessing available treatments. Dr. Miller is an Instructor in Dermatology and Medicine at Harvard Medical School and member of the Department of Dermatology and the Department of Medicine at Massachusetts General Hospital, where he is Director of the Center for Merkel Cell Carcinoma and Co-Director of the MGH-MEEI Non-Melanoma Skin Cancer Multi-Disciplinary Clinic.

Checkpoint will present updated interim safety and efficacy data from its ongoing registration-enabling clinical trial of cosibelimab in patients with metastatic cSCC at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020, to be held September 19-21, 2020. Checkpoint recently announced that the trial is over half enrolled, with full enrollment anticipated around year-end.

Registration link and webcast information:

Please click here to register for the event on Wednesday, August 19, 2020.
Following the event, the webcast will be available on the Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days.

On August 17, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, reported that the first patient has been dosed with Precigen’s PRGN-2009, a first-in-class, off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597) (Press release, Precigen, AUG 17, 2020, View Source [SID1234563712]). HPV-associated cancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

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The Phase I portion of the study will use 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and bintrafusp alfa (M7824), an investigational bifunctional fusion protein, in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with bintrafusp alfa as a neoadjuvant or induction therapy in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.

PRGN-2009 leverages Precigen’s proprietary UltraVector and AdenoVerse platforms to optimize HPV antigen design. Such design is differentiated from other therapies due to the gorilla adenovector’s large payload capacity and potential for repeat administration due to very low to no seroprevalence in the human population.

PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, with the laboratory of Dr. Jeffrey Schlom, Chief of the Laboratory of Tumor Immunology and Biology (LTIB), Center for Cancer Research (CCR), National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009. The Phase I/II clinical trial of PRGN-2009 is being conducted at the NIH Clinical Center and will be led by Dr. Julius Strauss, Co-Director of the LTIB’s Clinical Trials Group, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, CCR, NCI. For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

"We appreciate working in collaboration with such renowned partners at the NCI to achieve this important milestone in our efforts to develop a new off-the-shelf immunotherapy treatment option for patients with HPV-associated cancers," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are excited to investigate Precigen’s proprietary gorilla adenovector platform for the first time in a clinical setting and achieve this milestone during the COVID-19 global pandemic."

About HPV-associated Cancers
HPV infects the squamous cells that line the inner surfaces of certain organs and, consequently, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are referred to as adenocarcinomas.1 HPV-related cancers include cervical, oropharyngeal, anal, penile, vaginal, and vulvar.1 Nearly 44,000 HPV-associated cancers occur in the United States each year. Of these, approximately 25,000 occur in women and 19,000 occur in men.2 HPV is considered responsible for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and more than 60% of penile cancers.2 Recent studies indicate that about 70% of cancers of the oropharynx also may be related to HPV.2

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization.

For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

References
1 HPV and Cancer, National Institutes of Health. Accessed in July 2020
2 HPV-Associated Cancer Statistics, Centers for Disease Control and Prevention. Accessed in July 2020

Trademarks
Precigen, AdenoVerse, UltraVector, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company’s business, including the timing and progress of preclinical and clinical trials and discovery programs, the promise of the Company’s portfolio of therapies, the Company’s refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company’s non-healthcare businesses. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company’s clinical trial might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company’s most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.